COMPOSITION:
Each combipack contains:
(a) 1 Vial of Ceftriaxone & Tazobactam for Injection Each vial contains:
Ceftriaxone Sodium IP (Sterile) Eq. to Anhydrous Ceftriaxone 500 mg
Tazobactam Sodium IP (Sterile) Eq. to Tazobactam 62.5 mg
(b) 1 Ampoule of Sterile Water for Injections IP
Each Ampoule Contains: Sterile Water for Injections IP 5 ml
DESCRIPTION
Ceftriaxone sodium is a white to yellowish crystalline powder and Tazobactam sodium is a white crystalline powder, both are readily soluble in water. Each vial contains ceftriaxone sodium equivalent to 500 mg of ceftriaxone activity and tazobactam sodium equivalent 62.5 mg of tazobactam activity.
CLINICAL PHARMACOLOGY
Ceftriaxone
Ceftriaxone is a third-generation beta-lactam antibiotic from the cephalosporin group. Ceftriaxone selectively and irreversibly inhibits bacterial cell wall synthesis by binding to transpeptidases, which are penicillin-binding proteins (PBPs) that catalyze the cross-linking of the peptidoglycan polymers forming the bacterial cell wall. The peptidoglycan cross-linking activity of PBPs is a construction and repair mechanism that normally helps to maintain bacterial cell wall integrity, so the inhibition of PBPs leads to damage and destruction of the cell wall and eventually
Ceftriaxone is effective against both Gram-positive and Gram negative bacteria. Gram-positive susceptibility includes certain Staphylococcus and Streptococcus organisms.
Gram-negative susceptibility includes Bacteroides spp.
Enterobacter spp. E. coll, Klebsiella spp, Proteus spp.
Pseudomonas aerogenosa and Serratia spp.
Ceftriaxone is not absorbed after oral administration and must be given parenterally, It is widely distributed throughout the body, CSF levels are higher when meninges are inflamed.
Ceftriaxone crosses the placenta and enters maternal milk in low concentrations. Ceftriaxone is excreted by both renal and non-renal mechanisms. In dogs, ceftriaxone bioavailability after IM administration equal that of IV, but peak levels occur much faster after IM (approx. 30 minutes) total area under the curve is similar for IM routes. Elimination half-life is longer after IM (1.17 hrs) than IV administration (0.88 hrs).
Tazobactam
Tazobactam is a penicillanic acid sulfone derivative with beta-lactamase inhibitory properties. It enhances the activity of beta-lactam antibacterials against beta-lactamase-producing bacteria.
The beta-lactamase inhibitors are a specific class of drugs with little antibacterial effects of their own, but they act to inhibit beta-lactamase enzyme.
INDICATIONS
PROMICEF TAZO injection is indicated for the treatment of the following infections caused by beta-lactam antibacterial resistant organisms in dogs and cats: Respiratory tract infections, Bacterial dermatological infections, Urinary tract infections, Bone & Joint Infection, Bacterial septicemia, Intra-abdomínal infection, Meningitis and other systemic bacterial infections.
DOSAGE AND ADMINISTRATION
In dogs, the usual dose is 15 to 50 mg/kg every 12 to 24 hours intramuscularty or intravenously.
In cats, the usual dose is 25 to 50 mg/kg every 12 hours intramuscularly or intravenously.
Ceftriaxone & Tazobactam dose is based on equivalent of ceftriaxone dose (Ceftriaxone 500mg is
equivalent to
Ceftriaxone and Tazobactam for Injection 562.5 mg).
The dose and duration: The duration of administration depends on the condition being treated, response to the medication, and / or as directed by your veterinarian.
DIRECTION FOR USE
Dissolve the contents in 5 ml of Sterile Water for Injections IP for IV use, 2 ml of Sterile water for injections IP for IM use. The constituted solution should be used immediately after preparation.
WARNINGS AND PRECAUTIONS
PROMICEF TAZO should not be used in dogs and cats with known hypersensitivity or allergy to ceftriaxone/tazobactam
PROMICEF TAZO injection is not for oral use. For IV / IM use in dogs and cats.
Keep medicine out of reach of children.
PREGNANCY AND LACTATION SAFETY
No teratogenic effects were demonstrated in reported studies in pregnant mice and rats given up to 20X labeled dose of ceftriaxone. No such study reported for tazobactam.
Ceftriaxone/Tazobactam is distributed into milk in low concentrations and is unlikely to pose risk to nursing offspring of dogs and cats.
ADVERSE REACTIONS
Ceftriaxone Induced Steven-Johnson Syndrome (SJS).
Nausea, vomiting and diarrhea may occasionally be seen.
Increased serum concentrations of liver enzymes, BUN, creatinine and urine casts may occur following treatment with ceftriaxone/tazobactam. A false-positive Coombs' test and false-positive urine glucose may occur.
Hematological side effects like eosinophilia, thrombocytosis and leucopoenia may or may not be observed following treatment with ceftriaxone/tazobactam.
Intramuscular injections can be painful, and repeated
Intravenous administration may lead to local phlebitis.
DRUG INTERACTIONS
Parenteral aminoglycoside and cephalosporins should not be
used concurrently,
Concomitant use with calcium containing solutions should be avoided.
STORAGE
Store below 30°C. Protect from light & moisture.
Do not freeze.
PRESENTATION
500 mg Ceftriaxone and 62.5 mg of Tazobactam in powder form.
5 ml sterile water for injection.
562.5 mg Vial with WFI
Dosage:
15 to 25 mg/kg
every 24 hours through IM,
SC or IV administration
in dogs & cats
